When you need top global experts with meaningful expertise in key aspects of clinical trials, THINK THEOREM.
One thing that sets Theorem apart from other CROs is the quality of our executive management. These are men and women of extraordinary accomplishment, many with multiple advanced degrees and decades of experience with some of the world’s most influential drug development teams. Especially in areas such as medical device trials, combination device trials and biostatistical analysis, Theorem has few peers.
When you need the knowledge that only years of experience at the top levels of the industry can give you, THINK THEOREM.
John Potthoff, PhD
President and CEO
A respected industry leader with more than 20 years of focused experience, Dr. John Potthoff oversees Theorem’s global operations and long-term growth strategy. Prior to joining Theorem, John was COO of INC Research, a company for whom he achieved a compound annual growth rate of 40 percent year after year for multiple years. John was also the founder and president of Tanistry Inc., a CRO specializing in CNS indications, before it was acquired by INC Research in 2001. Before founding Tanistry, he was an executive of PPD Development. John earned his bachelor’s, master’s and doctoral degrees in psychology from the University of Texas, where he is also an adjunct professor in the Department of Psychology.
Marc Hoffman, MD
Senior Vice President and General Manager, Biopharmaceutical Development
In addition to leading biopharmaceutical development, overseeing strategy for drug and biologic product development, Dr. Marc Hoffman is responsible for leading the medical, regulatory and pharmacovigilance operations as well as the clinical supply function. A 25-year veteran of some of the most respected names in clinical research, Marc was vice president of medical and scientific affairs for Covance Inc. before joining Theorem. Prior to Covance, he worked in a variety of clinical development, medical affairs and regulatory roles for organizations including Hospira Inc., Baxter Healthcare Corporation, Kendle and PAREXEL. Marc earned his bachelor’s degree in psychology from Emory University and his MD from the American University of the Caribbean School of Medicine. He went on to earn a diploma of pharmaceutical medicine from the Royal College of Medicine, UK, and pursued management studies at the Wharton School and the Lake Forest Graduate School of Management.
Senior Vice President of Global Clinical Development
In a career spanning more than 25 years in pharmaceutical research, Brian Mooney has developed notable expertise in global project management. After joining Pharmaceutical Research Associates International (PRA) as director of project management in 1996, Brian held a succession of positions with increasing responsibilities, including vice president of contracts and proposals, vice president of countries groups, vice president of global project management, and finally senior vice president of project services. He was also responsible for the creation, expansion and oversight of multiple departments, including Global Project Management, Global Study Start-Up, Business Solutions and Central Document Management. Prior to joining PRA, Brian was project manager and program director for Corning Besselaar. He began his career as a microbiologist for MAS Laboratories. Brian received his bachelor’s degree in biology with a minor in chemistry from Trenton State College in Trenton, New Jersey.
Senior Vice President and General Manager, Clinical Analytics
With more than 21 years of statistical experience, Mark Penniston has managed, analyzed and designed trials of every size and in all phases. As senior vice president and general manager of Theorem’s clinical analytics, he leads a team of global professionals in clinical data management, biometrics and medical writing. Since joining Theorem Clinical Research in 1996, Mark has served in positions of increasing responsibility in global clinical data management, biometrics and clinical writing. Prior to Theorem, he held positions with Janssen Research Foundation, Covance and Pfizer. A seasoned professional with a broad portfolio of therapeutic experience, Mark earned his master’s and bachelor’s degrees from the University of Massachusetts in Amherst. He has presented, written for and hosted numerous conferences and serves on executive committees for technical service users groups.
D. Lee Spurgin, Jr., PhD
Senior Vice President and General Manager, Medical Device and Diagnostic Development
Dr. Lee Spurgin has been an integral part of Theorem’s growth and change since he joined the organization in 1997. With a career spanning more than 20 years and broad exposure to medical device studies in key therapeutic areas, Lee has held a variety of clinical positions including senior vice president of scientific affairs and development, vice president global services, and director of project management. Lee earned his PhD in management from LaSalle University and an MA from National University. He received his undergraduate degree in health care administration from Southern Illinois University. He is a member of a number of professional associations, including the Drug Information Association (DIA), American Academy of Dermatology (AAD) and Regulatory Affairs Professionals Society (RAPS).
Brian Bollwage, JD
Vice President of Global Regulatory Affairs
In a career spanning more than 30 years with almost all of it focused on regulatory affairs, Brian Bollwage is a leading authority on regulatory law. Prior to joining Theorem Clinical Research, Brian was director of global regulatory science for Bristol-Myers Squibb and the founder and managing partner of FDA Liaison, LLC. Among other executive posts, he was executive director and regulatory counsel for global regulatory intelligence at i3 Research, vice president for regulatory affairs for INC Research, and director of the FDA Liaison Group at Covance. He is an assistant professor of food and drug law at Temple University and has published extensively on regulatory affairs topics. Brian earned a bachelor's degree in biology from the University of Bridgeport in Connecticut, a master's in biology from Rutgers University in New Jersey, an MBA from Fairleigh Dickinson University in New Jersey, and a JD from Rutgers. He is the member of several professional societies, including the American Bar Association, the Drug Information Association and the Regulatory Affairs Professionals Society.
Vice President of Global Business Development
Sara Davis, vice president of global business development, joins Theorem with more than 15 years of sales and management experience and a proven track record of building industry-leading business development teams. Beginning her career as an account executive with PRA International, Sara has successfully sold in both the biotech and pharmaceutical industries. Her depth of experience spans across a variety of market segments including both short-term tactical deals to large, multiyear, multimillion-dollar strategic partnerships. Sara graduated with a Bachelor of Science from the University of Wisconsin Oshkosh. Sara drives business development growth plans globally for Theorem.
Senior Vice President and Chief Financial Officer
A respected financial veteran with top-tier experience in health care and contract research organizations, Jason Monteleone’s responsibilities for Theorem Clinical include finance, accounting, human resources, information technology, legal, contracts and facilities. Prior to joining Theorem, Jason held positions as senior director of financial planning and analysis and as director of global finance operations, global clinical development at MDS Pharma Services; global finance director, customer care at VIASYS Healthcare; and senior business analyst at GE Capital, TIP Division among other key positions. He earned his B.S. degree in accounting from Millersville University of Pennsylvania and his MBA from Temple University, Fox School of Business and Management.
Vice President of Global Clinical Quality Assurance and Compliance
An industry expert with more than 10 years in academic research at the University of Essen and 20 years of industry experience primarily in quality assurance in Pharma and CROs, Angelika Tillmann keeps a firm grip on quality at Theorem Clinical Research. As vice president of global clinical quality assurance and compliance, she oversees the conduct of clinical trials, system and process audits, vendor qualification, preparation for inspections, compliance with current regulations, corrective and preventive action programs, risk assessments and SOP development. As the head of the Quality Council, she also oversees operational metrics. A graduate of the University of Essen in Germany with a degree in laboratory medicine, she is a Fellow of the British Association of Research Quality Assurance (BARQA) and the Secretary of BARQA’s GCP Committee. She also is a member of the German Society of Good Research Practice (DGGF) and a member of its newly founded working party on quality risk management. Angelika is the author of numerous industry publications and frequently presents at international conferences.